Phase I and pharmacokinetic study of carboplatin and paclitaxel with a biweekly schedule in patients with advanced non-small-cell lung cancer

Cancer Chemotherapy and Pharmacology

Volumn 52, Issue 1, 2003, Pages 67-72

  Ichiki, M ^a   Gohara, R ^a   Fujiki, R ^a   Hoashi, S ^a   Rikimaru, T ^a   Aizawa, H ^a  

^a KURUME UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Carboplatin; Non small cell lung cancer; Paclitaxel; Pharmacokinetic study; Phase I study

Indexed keywords

CARBOPLATIN; DEXAMETHASONE; DIPHENHYDRAMINE; DOCETAXEL; GEMCITABINE; GRANULOCYTE COLONY STIMULATING FACTOR; PACLITAXEL; RANITIDINE; SEROTONIN 3 ANTAGONIST;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; DISEASE COURSE; DISTRIBUTION VOLUME; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INFUSION; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL TOXICITY; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; LEUKOPENIA; LIVER DYSFUNCTION; LIVER TOXICITY; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM TOLERATED DOSE; NAUSEA AND VOMITING; NEPHROTOXICITY; NEUROPATHY; NEUROTOXICITY; NEUTROPENIA; OTOTOXICITY; OUTCOMES RESEARCH; PERFORMANCE; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HALF-LIFE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; PACLITAXEL;

EID: 0042671116     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-003-0627-7     Document Type: Article

References (24)

1. ASCO Special Article (1997) Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer. Adopted on 16 May 1997 by the American Society of Clinical Oncology. J Clin Oncol 15:2996-3018
2. Belani CP, Aisner J, Hiponia D, Ramanathan R (1996) Paclitaxel and carboplatin in metastatic non-small cell lung cancer: preliminary results of a phase I study. Semin Oncol 23 [5 Suppl 12]:19-21
3. Belani CP, Kearns CM, Zuhowski EG, Erkmen K, Hiponia D, Zacharski D, Engstrom C, Ramanathan RK, Capozzoli MJ, Aisner J, Egorin MJ (1999) Phase I trial, including pharmacokinetic and pharmacodynamic correlations, of combination paclitaxel and carboplatin in patients with metastatic non-small-cell lung cancer. J Clin Oncol 17:676-684
4. Briasoulis E, Kalofonos H, Bafaloukos D, Samantas E, Fountzilas G, Xiros N, Skarlos D, Christodoulou C, Kosmidis P, Pavlidis N (2000) Carboplatin plus paclitaxel in unknown primary carcinoma: a phase II Hellenic Cooperative Oncology Group study. J Clin Oncol 18:3101-3107
5. Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, Wiltshaw E (1989) Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 7:1748-1756
6. Evans WK, Earle CC, Stewart DJ, Dahrouge S, Tomiak E, Goss G, Logan D, Goel R, Gertler SZ, Dulude H (1997) Phase II study of a one hour paclitaxel infusion in combination with carboplatin for advanced non-small cell lung cancer. Lung Cancer 18:83-94
7. Glorieux P, Ortmanns P, Marien S, Degives R, Degraeve D, Potvin M, Grauwels D, Schallier D (2001) Multi-center study of two dose levels of paclitaxel with carboplatin in locally advanced and metastatic non-small cell lung cancer (NSCLC). Anticancer Res 21:1487-1494
8. Greco FA, Hainsworth JD (1998) One-hour paclitaxel plus carboplatin for advanced non-small-cell lung cancer. Oncology 12 [1 Suppl 2]:71-73
9. Grem JL, Tutsch KD, Simon KJ, Alberti DB, Willson JK, Tormey DC, Swaminathan S, Trump DL (1987) Phase I study of taxol administered as a short iv infusion daily for 5 days. Cancer Treat Rep 71:1179-1184
10. Hainsworth JD, Urba WJ, Hon JK, Thompson KA, Stagg MP, Hopkins LG, Thomas M, Greco FA (1998) One-hour paclitaxel plus carboplatin in the treatment of advanced non-small cell lung cancer: results of a multicentre, phase II trial. Eur J Cancer 34:654-658
11. Helsing M, Thaning L, Sederholm C, Sederholm C, Lamberg K, Martinsson JE, Ek L, Mansson T, Andersson L, Hero U, Anjedani D, Svennson G (1999) Treatment with paclitaxel 1-h infusion and carboplatin of patients with advanced non-small-cell lung cancer: a phase II multicentre trial. Lung Cancer 24:107-113
12. Huizing MT, Giaccone G, van Warmerdam LJ, Rosing H, Bakker PJ, Vermorken JB, Postmus PE, van Zandwijk N, Koolen MG, Huinink WW, van der Vijgh WJ, Bierhorst FJ, Lai A, Dalesio O, Pinedo HM, Veenhof CH, Beijnen JH (1997) Pharmacokinetics of paclitaxel and carboplatin in a dose-escalating and dose-sequencing study in patients with non-small-cell lung cancer. J Clin Oncol 15:317-329
13. Jelliffe RW (1973) Creatinine clearance: badside estimate. Ann Intern Med 79:604-605
14. Johnson DH, Paul DM, Hande KR, Shyr Y, Blanke C, Murphy B, Lewis M, DeVore RF III (1996) Paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a phase II trial. J Clin Oncol 14:2054-2060
15. Kakolyris S, Kouroussis Ch, Souglakos J, Mavroudis D, Agelaki S, Kalbakis K, Androulakis N, Vardakis N, Vamvakas L, Georgoulias V (2001) A phase I clinical trial of topotecan given every 2 weeks in patients with refractory solid tumors. Oncology 61:265-270
16. Kearns CM, Gianni L, Egorin MJ (1995) Paclitaxel pharmacokinetics and pharmacodynamics. Semin Oncol 22 [3 Suppl 6]:16-23
17. Kelly K, Pan Z, Murphy J, Huffman DH, Bunn PA Jr (1997) A phase I trial of paclitaxel plus carboplatin in untreated patients with advanced non-small cell lung cancer. Clin Cancer Res 3:1117-1123
18. Kelly K, Crowley J, Bunn PA, Presant CA, Grevstad PK, Moinpour CM, Ramsey SD, Wozniak AJ, Weiss GR, Moore DF, Israel VK, Livingston RB, Gandara DR (2001) Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial. J Clin Oncol 19:3210-3218
19. Langer CJ, Leighton JC, Comis RL, O'Dwyer PJ, McAleer CA, Bonjo CA, Engstrom PF, Litwin S, Ozols RF (1995) Paclitaxel and carboplatin in combination in the treatment of advanced non-small-cell lung cancer: a phase II toxicity, response, and survival analysis. J Clin Oncol 13:1860-1870
20. Roychowdhury DF, Desai P, Zhu YW (1997) Paclitaxel (3-hour infusion) followed by carboplatin (24 hours after paclitaxel): a phase II study in advanced non-small cell lung cancer. Semin Oncol 24 [4 Suppl 12]:37-40
21. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH (2002) Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346:92-98
22. Shyr Y, Choy H, Cmelak P, Mohr P, Johnson DH (1998) Pattern of practice survey non-small cell lung cancer (NSCLC) in US. Proc Am Soc Clin Oncol 17:463a
23. Tamura T, Sasaki Y, Nishiwaki Y, Saijo N (1995) Phase I study of paclitaxel by three-hour infusion: hypotension just after infusion is one of the major dose-limiting toxicities. Jpn J Cancer Res 86:1203-1209
24. WHO (1979) Handbook for reporting results of cancer treatment (offset publication no. 48). World Health Organization, Geneva